Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
NCT ID: NCT00914589
Last Updated: 2017-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
479 participants
INTERVENTIONAL
2009-07-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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FXIII17.5IU/Kg
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
FXIII35IU/Kg
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Placebo
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
placebo
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Interventions
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catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
catridecacog
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
placebo
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known or suspected allergy to the used antifibrinolytic agent
* Refusal to receive blood or blood product
* Planned surgery including the aortic arch and/or descending aorta
* Planned surgery including any implantable ventricular assist device
* Adult congenital heart diseases
* Two or more previous cardiac surgery procedures
* Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
* Weight above 140 kg
18 Years
80 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Durham, North Carolina, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Allentown, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Providence, Rhode Island, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Montreal, , Canada
Novo Nordisk Investigational Site
Ottawa, , Canada
Novo Nordisk Investigational Site
Québec, , Canada
Novo Nordisk Investigational Site
Toronto, , Canada
Novo Nordisk Investigational Site
København Ø, , Denmark
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Frankfurt am Main, , Germany
Novo Nordisk Investigational Site
Ludwigshafen, , Germany
Novo Nordisk Investigational Site
München, , Germany
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Ramat Gan, , Israel
Novo Nordisk Investigational Site
Bologna, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
San Donato Milanese (MI), , Italy
Novo Nordisk Investigational Site
Numakunai, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Cambridge, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Southampton, , United Kingdom
Countries
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References
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Song HK, von Heymann C, Jespersen CM, Karkouti K, Korte W, Levy JH, Ranucci M, Saugstrup T, Sellke FW. Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Ann Thorac Surg. 2014 May;97(5):1630-5. doi: 10.1016/j.athoracsur.2013.12.025. Epub 2014 Mar 19.
Karkouti K, von Heymann C, Jespersen CM, Korte W, Levy JH, Ranucci M, Sellke FW, Song HK. Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: a randomized, placebo-controlled, multicenter clinical trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):927-39. doi: 10.1016/j.jtcvs.2013.04.044. Epub 2013 Jun 29.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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JapicCTI-101078
Identifier Type: REGISTRY
Identifier Source: secondary_id
2008-006324-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1810-3540
Identifier Type: -
Identifier Source: org_study_id
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